Cyber Ho

Powered Laser Surgical Instrument

Quanta System Spa

The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Cyber Ho.

Pre-market Notification Details

Device IDK170331
510k NumberK170331
Device Name:Cyber Ho
ClassificationPowered Laser Surgical Instrument
Applicant quanta System Spa via Acquedotto 109 Samarate (va),  IT 21017
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
quanta System Spa via Acquedotto 109 Samarate (va),  IT 21017
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-02
Decision Date2017-03-03
Summary:summary

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